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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02848599 |
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Date of registration:
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20/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery
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Scientific title:
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The Influence of Postoperative Analgesia on Systemic Inflammatory Response and Postoperative Cognitive Disfunction in Elderly Patients After Surgical Repair of Femoral Fractures |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02848599 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Gordana Kristek, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Hospital Centre Osijek |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients age 65 and over
- fracture of the proximal femur
- preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
- a written consent of the patient to participate in research
Exclusion Criteria:
- patient non-compliance
- ASA status IV and IV above
- patients younger than 65 years
- dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head
injuries,the use of opioids and benzodiazepines longer than a month before the
surgery; alcoholism; serious liver disease (class C according to Child-Pugh's
classification); severe kidney disease that require dialysis
- result of MMSE test (Mini-Mental State Examination) under 17
- the existence of any contraindications for the implementation of regional anesthesia
and one or other form of post-operative analgesia.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Cognitive Dysfunction
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Intervention(s)
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Drug: levobupivacaine
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Drug: morphine
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Primary Outcome(s)
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Changes in Cognitive Function
[Time Frame: Before, 24,48,72,96 and 120 hours after the surgery]
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Interleukin-6 Concentration in Peripheral Blood.
[Time Frame: Before, 24 and 72 hours after the surgery]
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Secondary Outcome(s)
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Changes in Fibrinogen Concentrations in Peripheral Blood
[Time Frame: Before, 24,72 and 120 hours after the surgery]
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Changes in Pain Intensity
[Time Frame: During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily until discharge]
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Changes in C-reactive Protein (CRP) Levels
[Time Frame: Before, 24,72 and 120 hours after the surgery]
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Postoperative Hospital Stay
[Time Frame: 14 days]
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Secondary ID(s)
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25-1:6563-3/2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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